Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Calcitriol
Drug ID BADD_D00337
Description Calcitriol is an active metabolite of vitamin D with 3 hydroxyl (OH) groups and is commonly referred to as 1,25-dihydroxycholecalciferol, or 1alpha,25-dihydroxyvitamin D3, 1,25-dihydroxyvitamin D3. It is produced in the body after series of conversion steps of 7-dehydrocholesterol from exposure to UV light. 7-dehydrocholesterol is converted to [DB00169] (vitamin D3) in the skin, which is then converted to [DB00146] in the liver and kidneys. [DB00146] undergoes hydroxylation to form calcitriol via 1α-hydroxylase (CYP27B1) activity [A26353]. Calcitriol is considered to be the most potent metabolite of vitamin D in humans [A3366]. Renal production of calcitriol is stimulated in response to PTH, low calcium and low phosphate [A26353]. Calcitriol plays a role in plasma calcium regulation in concert with parathyroid hormone (PTH) by enhancing absorption of dietary calcium and phosphate from the gastrointestinal tract, promoting renal tubular reabsorption of calcium in the kidneys, and stimulating the release of calcium stores from the skeletal system. In addition to promoting fatty acid synthesis and inhibiting lipolysis, calcitriol has been demonstrated to increase energy efficiency by suppressing UCP2 expression, which is modulated by signaling pathways of classical nuclear receptors (nVDR), where calcitriol acts as a natural ligand [A175615]. There is also evidence that calcitriol modulates the action of cytokines and may regulate immune and inflammatory response, cell turnover, cell differentiation [A26353]. Administered orally and intravenously, calcitriol is commonly used as a medication in the treatment of secondary hyperparathyroidism and resultant metabolic bone disease, hypocalcemia in patients undergoing chronic renal dialysis, and osteoporosis. It is also available in topical form for the treatment of mild to moderate plaque psoriasis in adults. Calcitriol is marketed under various trade names including Rocaltrol (Roche), Calcijex (Abbott) and Decostriol (Mibe, Jesalis).
Indications and Usage Used to treat vitamin D deficiency or insufficiency, refractory rickets (vitamin D resistant rickets), familial hypophosphatemia and hypoparathyroidism, and in the management of hypocalcemia and renal osteodystrophy in patients with chronic renal failure undergoing dialysis. Also used in conjunction with calcium in the management and prevention of primary or corticosteroid-induced osteoporosis.
Marketing Status Prescription; Discontinued
ATC Code A11CC04; D05AX03
DrugBank ID DB00136
KEGG ID D00129
MeSH ID D002117
PubChem ID 5280453
TTD Drug ID D0T2PL
NDC Product Code 72969-007; 63304-241; 55361-0007; 23155-663; 63304-239; 17478-932; 73309-261; 63415-0046; 45802-608; 65162-519; 51927-0033; 69452-207; 71335-1594; 62756-967; 63629-2445; 63629-8741; 71610-468; 11014-0021; 71335-1782; 0054-3120; 51407-169; 10888-8107; 11014-0013; 51407-170; 45408-001; 68083-316; 69452-208; 10888-8106; 10888-8112; 56161-202; 11014-0012; 23155-662; 43353-998; 17856-3120; 62756-968; 17478-931; 64980-447; 17478-831; 71610-521; 72789-058; 54239-004; 51927-0194; 30698-144; 58272-125; 12869-329; 43353-034; 0299-2012; 30698-911; 63629-8742; 55361-0001; 43353-138; 66499-0003; 0093-7352; 65162-576; 30698-143; 63304-240; 0093-7353; 10888-8111; 10888-5032
Synonyms Calcitriol | 1, 25-(OH)2D3 | 1,25-Dihydroxycholecalciferol | 1,25 Dihydroxycholecalciferol | 1,25-Dihydroxyvitamin D3 | 1,25 Dihydroxyvitamin D3 | D3, 1,25-Dihydroxyvitamin | 1 alpha,25-Dihydroxycholecalciferol | 1 alpha,25-Dihydroxyvitamin D3 | 1 alpha,25 Dihydroxyvitamin D3 | D3, 1 alpha,25-Dihydroxyvitamin | Bocatriol | Calcijex | Calcitriol KyraMed | KyraMed, Calcitriol | Calcitriol-Nefro | Calcitriol Nefro | Decostriol | MC1288 | MC-1288 | MC 1288 | Osteotriol | Renatriol | Rocaltrol | Silkis | Sitriol | Soltriol | Tirocal | 20-epi-1alpha,25-dihydroxycholecaliferol | 1,25-dihydroxy-20-epi-Vitamin D3 | 1,25 dihydroxy 20 epi Vitamin D3 | D3, 1,25-dihydroxy-20-epi-Vitamin | 1,25(OH)2-20epi-D3 | 1 alpha, 25-dihydroxy-20-epi-Vitamin D3
Chemical Information
Molecular Formula C27H44O3
CAS Registry Number 32222-06-3
SMILES CC(CCCC(C)(C)O)C1CCC2C1(CCCC2=CC=C3CC(CC(C3=C)O)O)C
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Parathyroid disorderParathyroid hormone/parathyroid hormone-related peptide receptorQ03431T677108130888; 8761540; 2161692; 8090332; 9368509; 3264876; 8205259
Parathyroid disorderOsteocalcinP02818Not Available8130888; 8761540; 2161692; 8090332; 9368509; 3264876; 8205259
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Renal failure20.01.03.0050.000784%Not Available
Rhinorrhoea22.02.05.010--
Seizure17.12.03.0010.001002%
Sensory disturbance17.02.07.006--Not Available
Sepsis11.01.11.0030.000392%
Skin discomfort23.03.03.006--Not Available
Skin disorder23.03.03.007--Not Available
Somnolence19.02.05.003; 17.02.04.006--
Tachycardia02.03.02.0070.001002%Not Available
Thirst14.03.02.007; 08.01.09.021--Not Available
Ulcer08.03.06.0010.001002%Not Available
Urinary tract infection20.08.02.001; 11.01.14.0040.001503%
Urine abnormality20.02.01.013--Not Available
Urticaria23.04.02.001; 10.01.06.0010.001503%
Vomiting07.01.07.0030.004007%
Weight decreased13.15.01.0050.001503%
White blood cell count increased13.01.06.0130.001002%Not Available
Mental status changes19.07.01.0010.001002%Not Available
Bone density decreased13.16.01.0010.001503%Not Available
Blood phosphorus decreased13.11.01.0150.001002%Not Available
Calciphylaxis14.04.01.0120.003005%Not Available
Epigastric discomfort07.01.02.004--Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Limb deformity15.10.03.0040.001002%Not Available
Growth retardation15.03.01.006--
Skin burning sensation17.02.06.009; 23.03.03.021--Not Available
Haemorrhage24.07.01.002--Not Available
Disturbance in sexual arousal19.08.04.003--Not Available
Blood alkaline phosphatase increased13.04.02.004--
Urine output increased13.13.03.002--Not Available
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